Back to resultsEfficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Botulinum Toxin A (Botox )
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Urgency, Urge incontinence, Botulinum toxin A, Quality of life
Eligibility Criteria
Inclusion Criteria: Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
Sites / Locations
- RAYMOND POINCARE Hospital
Outcomes
Primary Outcome Measures
Number of urgency and urge incontinence episodes at 3 months after injection
Secondary Outcome Measures
Number of micturition episodes on micturition chart per day
Mean value of volume of urine per micturition
Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D)
Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure
Number of pads used per day
Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day
Residual volume of urine after flowmetry
Maximal flow
Visual analogic scale for pain for procedure
Biologic modifications
Ultrasound of kidneys
Toxin A antibodies
Full Information
NCT ID
NCT00231491
First Posted
October 3, 2005
Last Updated
February 16, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00231491
Brief Title
Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
Official Title
Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder (OAB). A Multicenter Phase II, Randomized, Double-blind, Placebo Controlled 6 Month Study . VESITOX
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
Detailed Description
This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive bladder, Urgency, Urge incontinence, Botulinum toxin A, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin A (Botox )
Primary Outcome Measure Information:
Title
Number of urgency and urge incontinence episodes at 3 months after injection
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Number of micturition episodes on micturition chart per day
Time Frame
per day
Title
Mean value of volume of urine per micturition
Title
Mean delay between urgency and leakage Quality of life improvement by Iqol and EuroQol (EQ-5D)
Title
Urodynamic parameters : Volume at first contraction, volume at first desire to void, volume at urgency, maximal bladder capacity, maximal detrusor pressure
Title
Number of pads used per day
Title
Number of patients with less than 3 episodes per day of leakages by urge incontinence or urgency per day
Title
Residual volume of urine after flowmetry
Title
Maximal flow
Title
Visual analogic scale for pain for procedure
Title
Biologic modifications
Title
Ultrasound of kidneys
Title
Toxin A antibodies
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Overactive bladder with more than 3 episodes of urgency of urge incontinence per day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre DENYS, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAYMOND POINCARE Hospital
City
Garches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
16153215
Citation
Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52. doi: 10.1111/j.1464-410X.2005.05725.x.
Results Reference
background
PubMed Identifier
22036776
Citation
Denys P, Le Normand L, Ghout I, Costa P, Chartier-Kastler E, Grise P, Hermieu JF, Amarenco G, Karsenty G, Saussine C, Barbot F; VESITOX study group in France. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. Eur Urol. 2012 Mar;61(3):520-9. doi: 10.1016/j.eururo.2011.10.028. Epub 2011 Oct 25.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
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